Assesment of topical dexmedetomidine administration on intraoperative bleeding and quality of the surgical field during functional endoscopic sinus surgery in patients with chronic rhinosinusitis

Assesment of topical dexmedetomidine administration on intraoperative bleeding and quality of the surgical field during functional endoscopic sinus surgery

a randomized, triple blinded, controlled clinical trial with 44 patients with chronic rhinosinusitis candidate for functional endoscopic sinus surgery enrolled between september 2018 and September 2019

dexmedetomidine 2MCG/kg (in 2 ml with normal saline) will be coded by a technician who will not involve in other stages of study and 20 minutes before beginning of surgery will drop in each nostril. Quality of the field of surgery will evaluated at minutes 15,30,60 and 90.Also the amount of bleeding will be estimated from content of suction bottle.

Inclusion criteria: - Patients with chronic rhinosinusitis with or without polyposis candidate for FESS -18 - 60 years old -lack of history of bleeding disorders such as hemophilia - Normal coagulation tests - exclusion Criteria: - history of thromboembolic events - history of acute or chronic renal failure - use of anti-coagulant drugs since 5 days before surgery -history of cirrhosis- systemic diseases such as hypertension, diabetes, heart failure and cardiac rhythm disorders and coronary disorder- pregnancy - Allergy to dexmedetomidine -Sinonasal neoplasm -Detection of omplications during surgery or anesthesia

In all patients 20 minutes before the operation, nasal solution dexmedetomidine or saline will be used in each nasal side (1ml In each nostril).

Quality of the field of surgery and the amount of bleeding

For this purpose, the block randomization method will be used. Hence, six sheets will be prepared (letter A will be written on three sheets and letter B on the other three sheets for the Intervention and Control group). The sheets will be mixed together and placed in the drawer of the table. By referring to each of the eligible patients, one of the sheets will drawn randomly and based on the sheet A or B the patient will be allocated into one of the two intervention and control groups. The drawn sheets will not be returned to the drawer until all six sheets will be drowned.

For both intervention and control groups, syringes with unspecified content (saline or dexmedetomidine) are used twenty minutes before surgery. The saline solution is drawn in a syringe similar to the dexmedetomidine solution (syringes will be prepared and identified with codes A and B by an operating room technician who will not participate in the course of the research project. So the codes will remain hidden till the end of the study and analysis). Therefore, the study will be blinded for the patients, the surgeon and the data analyser.